Psychological DistressENYOY:nextstepNCT07594756
Investigating the (Cost-)Effectiveness of an Online Social Therapy Platform (ENYOY) for Young People Aged 16-25 on Mental Healthcare Waiting Lists
A study testing ENYOY and Care As Usual in people with Psychological Distress, run by Academisch Medisch Centrum - Amsterdam UMC Research BV at 1 site in Netherlands.
Trial summary
This study, run by Amsterdam UMC in the Netherlands, looks at whether an online mental health platform called ENYOY can help reduce psychological distress in young people aged 16 to 25 who are waiting for mental health care. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Psychological Distress
- What is being tested?
- ENYOY and Care As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 May 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-25 years
- On a waiting list for mental healthcare.
- Able and willing to consent.
- A score of 10 or higher on the CORE-10 questionnaire.
- Personal and private access to a computer, smartphone or tablet.
- Ability and willingness to nominate an emergency contact person, such as a close family member.
Who cannot join
- Insufficient command of the Dutch language.
- Present with acute suicidal behavior or imminent risk of harm to self.
- If their psychiatric symptoms are due to an organic cause.
- Prior exposure to ENYOY or MOST.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Fenna Hellegers, +316 27326769, f.hellegers@amsterdamumc.nl
About this study
Official title: ENgage YOung People earlY: the Next Steps
This study, run by Amsterdam UMC in the Netherlands, looks at whether an online mental health platform called ENYOY can help reduce psychological distress in young people aged 16 to 25 who are waiting for mental health care.
Young people can take part if they are experiencing mental health problems and are currently on a waiting list for mental health care. The study lasts 12 months. During this time, participants complete questionnaires four times: at the start of the study and after 3, 6, and 12 months.
Read more
After joining the study, participants are randomly placed into one of two groups:
- Intervention group: receives access to the ENYOY platform plus care as usual.
- Control group: receives care as usual.
Young people in the intervention group can use the platform for the duration of the study, with three months of guidance from a coach and/or a peer with lived experience with mental health problems. The platform includes activities based on proven psychological methods. These activities help with issues such as low mood, anxiety, sleep problems, and low confidence. Participants also have access to a safe online community where young people can talk, share experiences, and support each other. The community is moderated to keep it safe and supportive.
Taking part may help reduce psychological distress and improve participants' mental health. There are no known risks associated with taking part in this study.
Participant recruitment will take place from May 2026 to December 2027. Final follow-up assessments are expected to be completed by December 2028. The study is funded by ZonMw.
For questions, you can contact Sascha Struijs (s.y.struijs@vu.nl) or Fenna Hellegers (f.hellegers@amsterdamumc.nl).
Read the detailed description
This study aims to evaluate the (cost-)effectiveness of a digital health platform (ENYOY) in reducing psychological distress among young people experiencing mental health difficulties who are currently on a waiting list for mental health care. Outcomes will be compared between participants who receive access to ENYOY in addition to care as usual and those who receive care as usual alone.
Young people in the Netherlands aged 16 to 25 years who report mental health difficulties and are currently on a waiting list for mental health care services are eligible to participate. Participants will complete self-report questionnaires at four time points (at the start of the study and at 3, 6, and 12 months).
Following the baseline assessment, participants will be randomly allocated to either the intervention condition (ENYOY plus care as usual) or the control condition (care as usual only). Participants in the intervention group will receive access to the ENYOY platform, including guidance for three months from a coach and/or a peer with lived experience with mental health difficulties. The platform provides personalised, self-directed therapeutic content and access to a moderated online peer community. Participants in the control group will continue to receive standard care.
Participation may contribute to a reduction in psychological distress and improvements in mental health outcomes. No adverse health risks are anticipated.
The study is conducted by Amsterdam UMC in the Netherlands. Participant recruitment will take place from May 2026 to December 2027. Final follow-up assessments are expected to be completed by December 2028. This study is funded by ZonMw.
For further information, please contact Sascha Struijs (s.y.struijs@vu.nl) or Fenna Hellegers (f.hellegers@amsterdamumc.nl).
- Conditions
- Psychological Distress
- Being tested
- ENYOY, Care As Usual
- Keywords
- Psychological distress, Young people, DMHI, ENYOY, MOST, Waiting list
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENYOYBehavioural
Also called MOST
ENYOY is an evidence-based digital mental health platform co-created with young people. It combines four main elements: interactive therapeutic content, guidence by coaches and/or peers with lived experience with mental health complaints, and a moderated online community. The therapeutic content is based on approaches like cognitive behavioral therapy and is tailored into "journeys" that match a young person's needs, such as improving mood, reducing anxiety, or building confidence. Users can explore activities and build a personal toolkit.
The online community offers young people a safe social space where they can connect, share experiences, and support each other. Engagement is encouraged through discussions, prompts, and optional anonymous participation. Safety is closely monitored through both human moderation and automated systems that detect risk.
Care As UsualOther
Young people in the control condition receive Care As Usual.
| Study group | Role | What they receive |
|---|---|---|
| Experimental condition | Experimental | Young people in this group receive access to the ENYOY platform, along with three months of guidance from a coach and/or a peer with lived experience of mental health difficulties, in addition to Care-As-Usual. Receives: Behavioral: ENYOY |
| Control condition | Other | Young people in the control condition receive Care As Asual. Receives: Other: Care As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation-10 measurement (Barkham et al., 2013). The minimum score is 0 and the maximum score is 40. Higher scores indicate higher levels of psychological distress.
Measured: At 3-month follow-up
Secondary outcomes (9)
Psychological distress
Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation-10 measurement (Barkham et al., 2013). The minimum score is 0 and the maximum score is 40. Higher scores indicate higher levels of psychological distress.
Measured: At 6-, and 12-month follow-up
Functioning
Functioning will be measured using Work and Social Adjustment Scale - youth version (WSAS-Y; Jassi et al., 2020). The minimum score is 0 and the maximum score is 40. Higher scores indicate greater impairment in functioning.
Measured: at 3-month, 6-month, and 12-month follow-up
Quality of life
Quality of life will be measured using the My Life Tracker measurement (MLT; Kwan et al., 2018). The minimum score is 0 and the maximum score is 100. Higher scores indicate a better quality of life. We will also use the Co-created outcome measure (YAG, YOUTHreach consortium). The minimum score is 0 and the maximum score is 124. Higher scores indicate a higher quality of life.
Measured: at 3-month, 6-month, and 12-month follow-up
Depression
Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The minimum score is 0 and the maximum is 27. Higher scores indicate a higher level of depression.
Measured: at 3-month, 6-month, and 12-month follow-up
Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder questionnaire-7 (GAD-7; Spitzer et al., 2006). The minimum score is 0 and the maximum score is 21. Higher scores indicate a higher level of anxiety.
Measured: at 3-month, 6-month, and 12-month follow-up
Self-esteem
Self-esteem will be measured using the Rosenberg Self-Esteem Scale questionnaire (RSES; Rosenberg, 1965). The minimum score is 0 and the maximum score is 30. Higher scores indicate a higher self-esteem.
Measured: at 3-month, 6-month, and 12-month follow-up
Health economic measure
Health economic measures will be using the EuroQol - 5 Dimensions - 5 Levels measurement (EQ-5D-5L;EuroQol Research Foundation, 2025; Herdman et al., 2011). The minimum score from the vife dimensions is 11111 and the maximum score is 55555. Higer scores indicate a better health status. We will also use a Resource Use Measurement developed by the YOUTHreach consortium to indicate the resourced used by the young person (RUM; YOUTHreach consortium).
Measured: at 3-month, 6-months, and 12-month follow-up
Social media use
Social media use will be measured using 8 items of the Compulsive Internet Use Scale (CIUS; Meerkerk et al. 2009). The minimum score is 0 and the maximum score is 32. Higher scores indicate a higher social media usage.
Measured: at 3-month, 6-month, and 12-month follow-up
Lonliness
Lonliness will be measured using the University of California, Los Angeles (UCLA) Loneliness Scale short form (V3; Russell, 1996). The minimum score is 8 and the maximum score is 32. A higher score indicate greater levels of lonliness.
Measured: at 3-month, 6-month, and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start18 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Amsterdam UMC Research BV
- Sponsor type
- University, hospital or other
- Collaborators
- Levvel, Psychiatric Clinic of Mondriaan Heerlen-Maastricht
- Responsible party
- Principal investigator, Prof. Dr. Arne Popma, Academisch Medisch Centrum - Amsterdam UMC Research BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594756
- Sponsor's protocol ID
- NL-010792
- Acronym
- ENYOY:nextstep
- Status last verified
- Sep 2026
- First submitted
- 6 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized research data from the individual research participants will be shared with the YOUTHReach consortium. See attachment for the registration of their study. Sharing IPD with other researchers is possible upon request.